FDA Device recall Z-0346-2022
Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
- FDA Device
- Class I
- terminated
- Published 2021-12-15
On 2021-12-15 the FDA classified a Class I recall of Puritan Bennett 980 Series Ventilator, 980X1ENDIPC by Covidien, citing manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0346-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-11-04 |
| Published | 2021-12-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Covidien |
| Distribution | US |
Product
Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
Reason
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Identifiers
| code_info | GTIN/UDI - 10884521172302 Serial Numbers: 35B1700447 35B1700405 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0346-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.